英文药名: Acuvail (Ketorolac Eye Drops)

中文药名: 酮咯酸氨丁三醇滴眼液

品牌药生产厂家: Allergan

药品简介

近日；美国食品和药物管理局已经批准Acuvail用于临床治疗白内障手术后的眼部疼痛，该药是一种非甾体类消炎药。白内障是导致老年人失眠的主要原因，而白内障手术也非常频繁，在美国每年都有3百万以上的病人接受该手术。
Acuvail（酮咯酸氨丁三醇滴眼液0.45%）是Allergan公司研发的一种新型滴眼液。该药是一种非甾体类消炎药，用于临床治疗白内障手术后的眼部疼痛，并于 2009年7月23日获得美国食品和药物管理局的批准。
白内障是导致老年人失眠的主要原因，而白内障手术也非常频繁，在美国每年都有3百万以上的病人接受该手术。

Acuvail保存在PH6.8的溶液中，并且添加了羧甲纤维素，该物质主要作用是可使该药粘在眼球表面与提高患者的舒适感。

Acuvail主要通过抑制COX-1 和COX-2酶来抑制炎症，研究表明该类酶能抑制前列腺素，而前列腺素是引起炎症和疼痛的主要物质。

“在Allergan的60年眼部护理发展历程中，我们非常高兴有机会给医师和病人提供先进有效的非甾体类抗炎药，缓解白内障手术后病人的痛苦”该公司的执行副主席Whitcup博士说道，“由于其稳定的结构式，良好的耐受性和服用剂量方便，这些特点将使该金象药为白内障手术患者提供一种有价值的新疗法。”
Acuvail眼药的疗效是通过两个多中心、随机、双盲、平行对照试验来评价的，该试验包括了500名受试者。该试验结果显示与对照组相比，该药效果很好，其中前房炎症消除率与对照组相比为53%比26%，该药缓解疼痛作用也较对照组疗效好。

证明Acuvail疗效的临床实验

“作为眼科医生，我喜欢给病人提供确实有效的治疗，Acuvail是一类酮咯酸药物，不需要防腐剂，每天两次服用的非甾体类药物，能够很好的缓解白内障病人术后炎症。” Eric博士说道。

Acuvail有望于2009年9月在美国上市。

Acuvail给医师和病人提供先进有效的非甾体类抗炎药，缓解白内障手术后病人的痛苦。
     
Acuvail

Indication(s):

Ocular pain and inflammation after cataract surgery.

Pharmacology:

Ketorolac tromethamine is a nonsteroidal anti-inflammatory drug (NSAID) with analgesic, anti-inflammatory and anti-pyretic properties. It is thought to exert its therapeutic effects through inhibition of prostaglandin biosynthesis.

Clinical Trials:

Two multicenter, randomized, double-masked, parallel group comparison studies were conducted to evaluate the effects of Acuvail on anterior chamber cell and flare, and ocular pain relief following cataract extraction with posterior chamber intraocular lens (IOL) implantation. Approximately 500 patients were enrolled in these studies. Clinical data showed that patients treated with Acuvail had a significantly higher incidence of clearing of anterior chamber inflammation compared to those who received vehicle (53% versus 26% of patients, respectively) at Day 14. Acuvail was also significantly superior to vehicle in resolving ocular pain. On Day 1 after cataract surgery, 72% of patients treated with Acuvail were pain free compared to 40% of patients treated with vehicle.

Through clinical studies, ketorolac tromethamine has not demonstrated any significant effect on intraocular pressure.

Legal Classification:

Rx

Adults:

1 drop twice daily beginning 1 day prior to surgery, continue on day of surgery and through first 2 weeks post-op. May be administered in conjunction with other topical ophthalmic medications (eg, alpha-agonists, beta-blockers, cycloplegics, and mydriatics); drops should be administered at least 5 minutes apart.

Children:

Not recommended.

Warnings/Precautions:

Do not administer while wearing contacts. Aspirin sensitivity. Bleeding tendencies. Complicated or repeat ocular surgeries. Corneal defects/denervation. Ocular surface diseases. Diabetes. Rheumatoid arthritis. May delay wound healing. Monitor cornea; discontinue if corneal epithelial breakdown occurs. Pregnancy (Cat.C): avoid in late pregnancy. Nursing mothers.

Interaction(s):

May potentiate oral anticoagulants, others that prolong bleeding. Concomitant topical steroids may increase potential for delayed healing.

Adverse Reaction(s):

Increased intraocular pressure, conjunctival hyperemia and/or hemorrhage, corneal edema, keratitis, ocular pain, headache, tearing, blurred vision, increased bleeding (including hyphemas).

How Supplied:

Single-use vials (0.4mL)—30

Last Updated:

9/10/2009